Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: particulates
Details on test material:
- Substance type: organic
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
In half of the animals the treatment lasted for 30 seconds (time of flushing with water)
In half of the animals the treatment was not stopped.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in half of the animals the eye was flushed with 10 ml lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours, unrinsed
Score:
ca. 13
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: maximum possible score is 80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours, unrinsed
Score:
ca. 13
Max. score:
20
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours, unrinsed
Score:
ca. 10
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 96 hours, unrinsed
Score:
ca. 7
Max. score:
15
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days, unrinsed
Score:
ca. 3.3
Max. score:
5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours - 7 days, unrinsed
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: maximum possible score is 10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours, unrinsed
Score:
ca. 15
Max. score:
16
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: maximum possible score is 20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours, unrinsed
Score:
ca. 14
Max. score:
16
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours, unrinsed
Score:
ca. 11
Max. score:
14
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 96 hours, unrinsed
Score:
ca. 7
Max. score:
12
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days, unrinsed
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The effects are mild, however cornea effects are not fully reversible within 7 days.
Executive summary:

The effects are mild, however cornea effects are not fully reversible within 7 days.